SURG-E-TROL SYSTEM I AND SYSTEM II

SURG-E-TROL SYSTEM I AND SYSTEM II is an FDA 510(k)-cleared medical device (K890622) manufactured by Mentor O & O, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 3, 1989. Regulation: 8.